Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

Trial Information

Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

Patients with vitiligo received 6-9 ultraviolet B treatments, 2 to 3 times weekly. Minimal
erythema dose (MED) testing was done at baseline and after all treatments; the percent
change in MED was analysed as a measure of photoadaptation. The percent decrease in
cyclobutane pyrimidine dimers (CPDs) over 24 hours after a single exposure of 1 MED was
analysed on vitiliginous and normal skin.

Inclusion Criteria:

For inclusion, the subject must:

1. Be at least 18 years old

2. Be otherwise healthy

3. Have a diagnosis of vitiligo affecting > 5% body surface area (BSA)

4. Have two depigmented lesions on opposite sides of the body that can be biopsied at
the end of TARGETED UVB PHOTOTHERAPY treatment

6. Have a negative pregnancy test at baseline if female of childbearing potential

7. Be able to understand the requirements of the study, the risks involved, and is able
to sign the informed consent form

8. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

Subjects will be excluded if any of the following apply:

1. Women who are lactating, pregnant, or planning to become pregnant

2. Patients with a recent history of serious systemic disease

3. Patients with a known history of photosensitivity

4. Concomitant use of systemic or topical treatments for vitiligo. Patients must
discontinue PUVA or oral corticosteroid therapy for 4 weeks prior to the start of any
treatment. If a patient is taking any vitamins or dietary supplements, the patient
must discontinue them for the duration of the study. Topical therapy such as
corticosteroids, topical immunomodulators (e.g., Protopic or Elidel), vitamin D
derivatives (e.g., Dovonex), or UVB phototherapy must be discontinued for 2 weeks
prior to the start of study treatment.

5. Patients diagnosed to be immunosuppressed for any reason (e.g., HIV infection, lupus,
cancer, organ transplant, or chronic use of oral immunosuppressive agents).

6. Any reason the investigator feels the patient should not participate in the study

Type of Study:

Interventional

Study Design:

N/A

Principal Investigator

Iltefat Hamzavi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Dermatology, Henry Ford Health System

Authority:

United States: Institutional Review Board

Study ID:

IRB3701

NCT ID:

NCT00367224

Start Date:

January 2006

Completion Date:

May 2008

Related Keywords:

Vitiligo

vitiligo

tolerance

ultraviolet B.

Vitiligo

Name

Location

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